510(k) K885254
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1989
- Date Received
- December 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Device Class
- Class I
- Regulation Number
- 862.2400
- Review Panel
- CH
- Submission Type